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FDA 510(k) Application Details - K053548
Device Classification Name
Device, Neurovascular Embolization
More FDA Info for this Device
510(K) Number
K053548
Device Name
Device, Neurovascular Embolization
Applicant
PROTEIN POLYMER TECHNOLOGIES, INC.
10655 SORRENTO VALLEY RD.
SAN DIEGO, CA 92121 US
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Contact
R. STEPHEN REITZLER
Other 510(k) Applications for this Contact
Regulation Number
882.5950
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Classification Product Code
HCG
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More FDA Info for this Product Code
Date Received
12/20/2005
Decision Date
01/30/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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